EP3366204B1

EP3366204B1 - Automated non-magnetic medical monitor using shape memory actuators

Info

Publication number: EP3366204B1
Application number: EP18161415.7A
Authority: EP
Inventors: Francis Patrick O'NEILL; Ronald Paul Consiglio
Original assignee: Koninklijke Philips NV
Current assignee: Koninklijke Philips NV
Priority date: 2012-06-13
Filing date: 2013-06-13
Publication date: 2023-03-15
Anticipated expiration: 2033-06-13
Also published as: US20150119691A1; CN104363821B; CN104363821A; EP2861134A2; EP3366204A1; WO2013186725A3; WO2013186725A2; JP6155330B2; BR112014030877A2; US10016140B2; JP2015521493A

Description

The present application finds particular application in magnetic resonance (MR)-compatible patient monitoring devices comprising shape memory alloy (SMA) components. However, it will be appreciated that the described technique may also find application in other patient monitoring devices, other magnetic device systems, or other SMA activation techniques.
US 2008/0056920 A1 discloses an actuator that includes a non-magnetic, electroactive material that is suitable to impart force upon application of an electric current.
WO 01/59344 A1 discloses a shape memory alloy actuator assembly for a fuel injector.
Conventional patient monitoring devices such as blood pressure cuffs and the like comprise metal components that are susceptible to magnetic fields (e.g., iron, nickel, cobalt, etc.). Patient monitoring devices comprising such metals can be affected by the large magnets of an MR scanner when the scanner is operational. For instance, a blood pressure cuff valve comprising ferromagnetic components can be affected such that the valve enters a closed state and the cuff acts as a tourniquet on the patient's arm during the MR scan. Moreover, ferromagnetic components of a peripheral device coupled to the patient, such as a pump or the like, which is intended to remain outside the MR scanner during the scan, can be drawn to the magnets of the MR scanner. Depending on the magnitude of the attraction to the magnets, the size and weight of the peripheral device, etc., the peripheral device can cause damage to other equipment in the area, the MR scanner, and/or the patient.
"Ferrous projectiles," as they are known, can cause damage to expensive medical equipment as well as patient injury. In fact, any ferrous material can be detrimental to patient safety. For instance, a patient who is an employee of a steel mill or other similar environment may have microscopic metal shavings in his eye(s) that go undetected before an MR scan. These ferrous projectiles are only detected once the MR scanner magnets have been activated, to the great discomfort of the patient. In the forgoing blood pressure cuff example, the magnetic field generated by the MR scanner magnets can pull a pneumatic valve closed in the cuff. This can result in discomfort to the patient, as well as a deficiency in vital sign information required or desired by a clinician during the MR scan.
Attempts to make MR-safe patient monitoring devices to date have not considered shape memory alloy metals due to the slow actuation period typically required to activate such alloys to achieve a desired response. In the case of patient monitoring devices, slow actuation times are not acceptable where patient vital sign measurements are desired periodically and frequently.
US 6494225 B1 discloses another embodiment of a proportional flow control valve using an SMA member.
The present application relates to new and improved systems and methods that facilitate rapid activation of shape memory alloy components in MR-compatible patient monitoring devices, which overcome the above-referenced problems and others.
The invention is defined by the independent claims. The dependent claims define advantageous embodiments.
In accordance with one aspect, a valve assembly is presented as defined in claim 1.
In accordance with another aspect, a method of actuating a magnetic resonance (MR)-compatible valve is presented as defined in claim 10.
In accordance with another aspect, a control circuit is presented as defined in claim 10.
Still further advantages of the subject innovation will be appreciated by those of ordinary skill in the art upon reading and understanding the following detailed description.
The innovation may take form in various components and arrangements of components, and in various steps and arrangements of steps. The drawings are provided for purposes of illustrating various aspects and are not to be construed as limiting the invention.
FIGURE 1 illustrates a cross-sectional view of a valve with a shape memory alloy (SMA) member (e.g., a spring) that is controlled to open and close an MR-compatible valve that can be employed in the bore of an MR scanner during a scan of a patient, in accordance with various aspects described herein.
FIGURE 2 illustrates a cross-sectional view of a valve in the closed position (e.g., after actuation of the SMA spring), in accordance with various aspects described herein.
FIGURE 3 illustrates a control circuit that actuates the SMA spring (Figs. 1 and 2) and protects it from power surges and/or other damaging events, in accordance with various aspects described herein.
FIGURE 4 illustrates a method of controlling an SMA spring in an MR-compatible valve assembly that can be employed in a pump, a blood pressure cuff, or any other device that is positioned in or near a bore of an MR scanner, in accordance with various aspects described herein.
In magnetic resonance imaging (MRI), powerful magnetic fields can interfere with, damage, cause premature failure in, and attract certain non-MR-safe instruments. The herein described systems and methods mitigate a need for electromagnetically sensitive components in favor of MR-safe shape memory alloy elements. The described valve, for instance, can be positioned near the patient during an MR scan without fear of damage to the valve, danger to the patient or clinician, or the MR machine.
In contrast to conventional valves, MR-safe valves employing shape memory materials are non-magnetic and therefore mitigate a danger of being drawn into the bore of an MR scanner. Their reliability is not affected by strong magnetic fields, and they do not require additional magnetic shielding that may add cost and weight and increases the risk to the patient, clinician and equipment from valve components being drawn towards the magnetic field of the MR machine. MR-compatible valves also mitigate a need for long hoses and cables because the MR-safe equipment may be brought closer to the MR machine and the patient during the MR procedure. Furthermore, the described MR-safe valve provides decreased electrical noise emissions, weight, and power consumption relative to piezoceramic materials. According to one aspect, a control circuit is provided that accelerates actuation of the shape memory material and protects the material from damage caused by power supply variation.
In this manner, the described examples facilitate using a shape memory actuator (e.g., the SMA spring or wire) to close a pneumatic valve. A shape memory element is used to act against the valve spring. The driver circuit quickly, safely and repeatably causes the shape memory actuator to act. The described innovation makes it possible to operate the valve in the MR environment, without risk of damage to the equipment from excessive magnetic fields. It also eliminates danger of the equipment being drawn into the bore and has applications to patient monitoring in the MR environment, and to any form of electromechanical switching, including pneumatic power switching in the MR environment.
FIGURE 1 illustrates a cross-sectional view of a valve 10 with a shape memory alloy (SMA) member (e.g., a spring) 12 that is controlled to open and close an MR-compatible value that can be employed in the bore of an MR scanner during a scan of a patient, in accordance with various aspects described herein. For example, the valve may be employed in a blood pressure cuff that monitors a patient's blood pressure during the MR scan. In other configurations, the valve is employed in other pneumatic or hydraulic valves or plungers (e.g., an intravenous drip regulator or the like) Advantages of shape memory materials over piezoceramic or other MR-compatible solutions include lower cost and less complex drive circuitry. The described valves and/or pumps are capable of operating in a high magnetic field without the use of additional magnetic shielding. Such valves and/or pumps enable the non-invasive monitoring of blood pressure, exhaled gasses and anesthetic gasses in the MRI environment. They may also be used to create MR-compatible electrical switches and valves. The valve assembly 10 of Figure 1 substitutes non-magnetic materials for conventional magnetic motor and solenoid components in, for example patient monitors and/or peripheral devices for use in the MR environment, while improving performance.
In one embodiment, the SMA member or spring 12 is a nitinol (e.g., nickel titanium) wire, strip, band, etc., which is coupled to a valve body 14 via fasteners 16, although any suitable SMA that exhibits changes in resistance with respect to temperature may be employed. The fasteners may be mechanical, chemical, or any other suitable type of fastener. The resistance of the nitinol wire changes when the wire is heated, and the wire shrinks. The SMA spring overlays a plunger 18 which, when depressed via the contraction of the wire, closes the valve. In one embodiment, configuration, an over-pressure spring (not shown) is provided between the SMA spring 12 and a top surface of the plunger 18.
A valve spring 20, shown in cross-section as a plurality of dots on either side of the plunger stem, biases the plunger upward to maintain the valve in an open state until the SMA spring is activated. In the vase where the valve 10 is a pneumatic valve, the valve spring 20 may be optional. When activated, the SMA spring forces the plunger downward to close the valve and stop the flow of air (or some other gas or liquid) by forcing the plunger tip 22 against a valve seat 24. A sensor 26 (e.g., a position sensor, a pressure sensor, or any other suitable sensor) is also included for determining whether the valve is open or closed.
According to the invention, once the sensor indicates to a control circuit 50 that the valve is closed, power supplied by the control circuit to the SMA spring switches from a constant power level (e.g., 3W or some other suitable power level) to a pulse width modulated power level (e.g., pulses with power levels between approximately 0W and 3W or the like) to reduce power consumption and prevent damage to the spring. In another embodiment, the constant power level is maintained for the duration of the operation of the valve and/or device in which the valve is employed.
A shape-memory alloy also known as SMA, smart metal, memory metal, memory alloy, muscle wire, smart alloy) is an alloy that remembers its original, cold-forged shape that returns to a pre-deformed shape by heating. The heat may be applied by external source or by passing a current through the material. Shape memory alloys include, but are not limited to copper-zinc-aluminum-nickel, copper-aluminum-nickel, beryllium-copper, copper bronze, and nickel-titanium. The activation of a memory shape alloy element is dependent on the temperature of the element and involves a change in state of the element material. The resistivity of the element changes with state change of the element.
FIGURE 2 illustrates a cross-sectional view of a valve 10 in the closed position (e.g., after actuation of the SMA spring), in accordance with various aspects described herein. The valve includes the SMA spring 12, which is coupled to a valve body 14 via fasteners 16. The actuated SMA spring biases the plunger 18 downward to maintain the valve in a closed state. The valve spring 20 biases the plunger upward to maintain the valve in an open state when the SMA spring is not activated. When activated, the SMA spring forces the plunger downward to close the valve and stop the flow of air (or some other gas or liquid) by forcing the plunger tip 22 against the valve seat 24. The sensor 26 is also included for determining whether the valve is open or closed.
FIGURE 3 illustrates a control circuit 50 that actuates the SMA spring (Figs. 1 and 2) and protects it from power surges and/or other damaging events, in accordance with various aspects described herein. The circuit comprises a high side current monitor comprising amplifier 52 to monitor the load current, a load voltage feedback point 54, a multiplier 56 to multiply the load current and load voltage, a pass element 58 that delivers current and voltage to the load R2 (e.g., the SMA wire 12), and an error amplifier 60 and pass element driver R1.
The circuit also comprises a voltage divider comprising resistors R3 and R4, as illustrated. The multiplier 56 evaluates current (I) and voltage (V) delivered to the load (e.g., the nitinol wire) and provides feedback signal that controls an input voltage the error amplifier 60. The voltage divider generates voltage feedback signal, while the current across R1 provides current feedback signal. The feedback signals are multiplied 56 and provided to the error amplifier 60 allowing constant power to be delivered to the load. In contrast to conventional SMA actuation approaches, which only control one of voltage or current, the described circuit 50 controls both current and voltage, and via the multiplier 56, controls power to provide a constant power level. Once the SMA spring is contracted and the plunger is depressed to close the valve, the constant power level is maintained, or according to the invention, it is reduced and pulse width modulation is applied to conserve power. The circuit response is tuned to allow control even when the control input is pulse width modulated to conserve power during activation state hold times. The described circuit energizes the SMA spring using a feedback of applied current times applied voltage, yielding applied power feedback. This feature allows consistent and fast activation by applying the maximum activation power in all activation and transition states.
When the SMA spring 12 is heated, resistance increases such that voltage across the spring increases and current through the spring decreases. In this event, the multiplier provides constant power to the SMA spring, but within an acceptable limit to avoid damage to the SMA spring. In one embodiment, the multiplier provides approximately 3W of power at approximately a 1V control input for a predetermined time period, and then the supplied power control signal is pulse width modulated between 0V and 1V to maintain the spring in a heated and contracted state while managing power consumption. In another embodiment, the multiplier provides approximately 3W of power at approximately a 1V control signal for a desired time period after which the valve is permitted to open. In any event, power through the load is limited to prevent burning and/or excessive contraction of the SMA spring.
FIGURE 4 illustrates a method of controlling an SMA spring in an MR-compatible valve assembly that can be employed in a pump, a blood pressure cuff, or any other device that is positioned in or near a bore of an MR scanner, in accordance with various aspects described herein. At 100, a constant power level is supplied to the SMA spring. In one example, the power level is in the range of approximately 2-5 W. In another example, the power level is approximately 3W. At 102, one or more valve parameters are monitored. For instance, a pressure in the valve or in a blood pressure cuff in which the valve is employed can be monitored. In another example, plunger position is monitored to facilitate determining whether the valve is in an open state or a closed state.
At 104, a trigger event is detected. For instance, once the pressure is determined to have exceeded a predetermined pressure threshold, the valve is determined to be closed. In another example, the determination that the position of the plunger is indicative of a closed valve is used as a trigger event. At 106, upon detection of the trigger event, and according to the invention, the constant power supplied to the SMA spring to actuate it is reduced and pulse width modulated (e.g., pulses with power levels between approximately 0W and 3W, or some other suitable reduced power level) to control power consumption while maintaining the SMA spring in its active state (e.g., contracted in the described example). In one configuration, a predetermined time period (e.g., on the order of milliseconds, seconds, etc.) is counted down between detection of the trigger event and adjustment of the supplied power. At 108, upon expiration of a predetermined operational time period, power to the SMA spring is ceased. For example, the predetermined operational time period may be approximately 40 seconds in order to permit the patient's blood pressure to be measured. In any event, the operational time period represents an approximate amount of time that the valve remains closed to perform its function in the device in which it is employed.
The innovation has been described with reference to several embodiments. Modifications and alterations may occur to others upon reading and understanding the preceding detailed description. It is intended that the innovation be construed as including all such modifications and alterations insofar as they come within the scope of the disclosure or the equivalents thereof. The scope of protection is defined by the appended claims.

Claims

A valve assembly comprising:
a magnetic resonance compatible valve (10) including a valve plunger (18) and a valve seat (24) and

a valve actuator for actuating the magnetic resonance compatible valve, the valve actuator including:
a shape memory alloy member (12) that when actuated depresses the valve plunger (18) to mate with the valve seat (24) in the magnetic resonance compatible valve;

a sensor (26) for determining whether the valve is open or closed; and

a control circuit (50) coupled to the sensor (26) and arranged for providing a power signal to the shape memory alloy member (12) to actuate the shape memory alloy member and maintain the shape memory alloy member in an active state, wherein:
the sensor (26) being configured to indicate to the control circuit (50) that the valve is closed,

characterised in that,

once the sensor indicates to the control circuit that the valve is closed, the control circuit being adapted to reduce and pulse width modulate the power signal.
The valve assembly according to claim 1, wherein the shape memory alloy member is a nitinol wire that contracts and biases the plunger downward when actuated.
The valve assembly according to claim 2, wherein the control circuit (50) supplies a constant power to the nitinol wire to actuate the nitinol wire.
The valve assembly according to claim 1, wherein the sensor (26) is a position sensor that detects that the plunger is in a closed position or an open position.
The valve assembly according to claim 1, wherein the sensor (26) is a pressure sensor that determines that the valve is in a closed state when pressure in the valve exceeds a predetermined pressure threshold.
The valve assembly according to any one of the preceding claims, wherein the control circuit (50) measures a current feedback signal and a voltage feedback signal and includes a multiplier (56) that multiplies the current feedback signal and the voltage feedback signal to generate a power feedback signal that is employed to provide a constant power signal to the shape memory alloy member (12) during actuation.
The valve assembly according to any one of the preceding claims, wherein the shape memory alloy member (12) comprises at least one of:
copper-zinc-aluminum-nickel;

copper-aluminum-nickel;

beryllium-copper;

copper bronze; and

nickel-titanium.
The valve assembly according to any one of the preceding claims, further comprising a valve spring (20) that biases the plunger upward against the shape memory alloy member (12).
The valve assembly according to any one of the preceding claims, adapted to be employed in a magnetic resonance compatible blood pressure monitoring system.
The valve assembly according to claim 1, wherein the control circuit (50) comprises:
a driver (58) that provides a constant power signal to the shape memory alloy member to actuate the shape memory alloy member and cause the shape memory alloy member to contract and depress the valve plunger to mate with the valve seat (24) in the magnetic resonance compatible valve to close the valve; and

a multiplier (56) that multiplies a measured current feedback representing a current through the shape memory alloy member by a measured voltage feedback representing a voltage over the shape memory alloy member to generate a feedback power signal that is used to maintain the constant power signal; and

wherein the control circuit is configured to, in response to an indication received from a sensor that the valve is closed, reduce and pulse width modulate the power signal to conserve power and maintain the shape memory alloy member in an active state.
The valve assembly according to claim 10, wherein the shape memory alloy member (12, R2) is a nitinol wire that biases a valve plunger downward when actuated to close the valve and maintain the valve in a closed state until the power signal is terminated.
A method of actuating a magnetic resonance compatible valve (10) including a valve plunger (18) and a valve seat (24), the method including:
providing a constant power signal to a shape memory alloy member (12) that when actuated depresses the valve plunger (18) to mate with the valve seat (24) in the magnetic resonance compatible valve;

monitoring at least one valve parameter to detect when the valve is closed;

adjusting the power signal upon detecting that the valve is closed, in order to maintain the shape memory alloy member in an active state while reducing power consumption,

characterised in that,

adjusting the power signal comprises reducing and pulse width modulating the power signal.
The method according to claim 10, wherein the shape memory alloy member is a nitinol wire that contracts and biases the plunger downward when actuated.
The method according to any one of claims 10 or 11, wherein the at least one monitored parameter is plunger position.
The method according to any one of claims 10-12, wherein providing a constant power signal comprises:
measuring a current feedback signal and a voltage feedback signal;

multiplying the current feedback signal by the voltage feedback signal to generate a power feedback signal; and

employing the power feedback signal to generate the constant power signal to the shape memory alloy member (12) during actuation.